BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    IMMUNICON CELLSAVE PRESERVATIVE TUBE

    K Number: K030596 · Decision Aug 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    6
    Review Days
    164

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    Basic Information

    Device Name
    IMMUNICON CELLSAVE PRESERVATIVE TUBE
    K Number
    K030596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunicon Corp.
    Date Received
    February 25, 2003
    Decision Date
    August 8, 2003
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Immunicon Corp.

    K Number Device Name
    K060110 CELLTRACKS ANALYZER II
    K050145 CELLTRACKA ANALYZER II
    K040077 IMMUNICON CELLTRACKS AUTOPREP SYSTEM
    K030263 IMMUNICON CELLTRACKS ANALYZER
    K022512 CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518